The Foundation For The Defense Of Citizens Against State Abuses (FACIAS) sent today an open letter to the National Agency for Medicines and Medical Devices (ANMDMR) asking the public to be informed about the real situation of Euthyrox stocks at the moment.
FACIAS's request comes as a result of numerous complaints from citizens that there are currently more than 1.2 million Euthyrox tablets in distributors' warehouses, but they are not being delivered to pharmacies.
In the appeal, FACIAS also requests information on the current situation of the marketing of Euthyrox by distributors, both for import and export, given that "ANMDMR does not stop the export of this drug in order to ensure the priority need of the domestic market".
Below is the full text of the request:
KINDLY INFORM
the following:
- What are the stocks of EUTHYROX currently held in distributors' warehouses, according to the records that the ANMDMR must keep, given that distributors are required to declare to the ANMDMR at the end of each day the stocks they have in their warehouses, and that the declaration is made automatically by computer system?
We would like you to answer this question as we have been informed that there are over 1.2 million Euthyrox tablets in distributors' warehouses at the moment, but they are not being delivered to pharmacies, creating a crisis in the pharmaceutical market and a vital health problem for patients diagnosed with thyroid problems.
According to the referrals we have received, there are currently 433,379 Euthyrox 100 mcg tablets, 332,314 Euthyrox 50 mcg tablets and 453,855 Euthyrox 25 mcg tablets in stock in distributors' warehouses.
- In view of the fact that, as of 31 March 2020, the company producing this medicine, MERCK KGa in Germany, has notified you that it is experiencing manufacturing problems, so that reduced quantities of Euthyrox will be delivered to the Romanian State. Can you please tell us why you have not made this known to the public and what measures have been taken by the institution to prevent the crisis caused by the lack of Euthyrox in pharmacies and, consequently, the health of patients?
- Why does the ANMDMR not also authorise ADEM to import this medicine, so that the necessary quantity of Euthyrox can be made available in all pharmacies so that thyroid patients can obtain it?
- What is the current situation regarding the marketing of Euthyrox by distributors, both for import and export, and, given the current crisis, what is the reason why ANMDMR is not stopping the export of this medicine in order to ensure that the needs of the internal market are met as a matter of priority, thus respecting the right to life and health of Romanian citizens?
We would like to point out that the public must be informed of the real situation which has led to the creation of this crisis at national level of Euthyrox in pharmacies, since the public perception is that they are waiting for Ministry Order 672/2020 with reference to Article 2 of the Regulation. 2 let. c) in order to export this medicine at a price higher than that charged for the sale of the medicine in Romania, which violates the right to health and life of Romanian citizens with thyroid problems - who need this medicine on a daily basis, as it is vital for them - the crisis being generated with the knowledge of the state authorities, who are thus endangering the fundamental rights of people with thyroid diseases, citizens of the Romanian State.
We also point out that the FACIAS's main purpose is to defend the rights of citizens against abuses committed by state institutions, in this case being the right to health and life of every citizen, as regulated and protected by the Romanian Constitution, and we have taken a stand, getting involved in solving several crises generated by the lack of vital medicines for patients, namely the immunoglobulin crisis, of cytostatics and treatment with Interferon Free for Hepatitis C patients, so we believe that our attitude and involvement is justified in this case as well regarding the crisis on the drug market regarding Euthyrox, as a result of its non-delivery to pharmacies by distributors in order to obtain profits generated by businesses that should be investigated by the competent institutions of the Romanian State.
As regards citizens suffering from thyroid insufficiency, statistically speaking, there are 5% of the country's population, i.e. 1 million patients, who are dependent on the active substance in Euthyrox, and by not taking the drug for a month, people can die, thus endangering not only their health, but even their lives.
In addition, the Ministry of Health has made it public that Euthyrox has been in distributors' warehouses in sufficient stock since 8 April 2020 and is being distributed in pharmacies, but it is not available in pharmacies because the distributors are not supplying it for the reasons mentioned above, namely the desire to sell it for export at a higher price than on the domestic market.
We consider that the information requested by the Foundation is of national public interest and concerns the field of activity of ANMDMR, according to which the institution has the obligation to supervise the production units, wholesale distribution and quality of medicines on the market, as well as the control of the use of medicines for human use, developing national strategies and policies in the field of medicines, monitoring the medicines market in order to ensure the control of the provision of services and the respect and application of the legislation in force. At the same time, it issues distribution authorisations for wholesale distributors of medicines for human use and carries out inspections of holders of marketing authorisations for medicines in order to verify compliance with their obligations, both in the field of pharmacy activities and their obligations under the legislation on medicines for human use, so that the current crisis generated by the lack of Euthyrox in pharmacies falls exclusively, as an obligation of solution, on the ANMDM institution.